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Oncology Newsfeed

  • CMS Releases Proposed NCD for CAR T-cell Therapy

    On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.

    With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”

    Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].

    Posted 2/15/2019
    Updated 2/28/2019

  • ACCC Joins Groups Expressing Concerns Over CMS' Interpretation of NCD for NGS

    The Association of Community Cancer Centers (ACCC) joined with more than 60 organizations in a January 31, 2019, letter to CMS Administrator Seema Verma expressing concern over recent developments in the agency's interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

    An overarching concern is that, although the NCD was requested for a somatic-based test, the new interpretation will result in Medicare Administrative Contractors (MACs) applying the NCD's terms to both somatic and germline NGS-based testing for patients with cancer. As a result, patient access to medically necessary and relevant testing of germline mutations in patients with cancer would be restricted, as would NGS-based testing (both somatic and germline) for Medicare beneficiaries with early-stage cancer.

    Read the Letter.

    Posted 1/4/2019

  • HHS Proposes Rule to End Middleman Drug Pricing Rebates

    On January 31, Health and Human Services Secretary Alex Azar proposed a rule to remove safe harbor protections for drug rebates paid by manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations. Through the removal of these protections, HHS and the Trump Administration continue their attempts to lower prescription drug prices and out-of-pocket costs. The proposal would also create new safe harbor protection for fixed fee service arrangements between manufacturers and PBMs. 

    Read the proposed rule here. Read the HHS press release here and the HHS fact sheet here.

    Posted 2/1/2019

  • FDA Approves Pemetrexed for Metastatic NSCLC

    On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

    Read the Eli Lilly and Company press release here.

    Posted 1/31/2019

  • CMS to Hold Two Webinars on Part D Payment Modernization Model

    The Center for Medicare & Medicaid Innovation (CMS Innovation Center) is hosting a webinar to provide a basic overview of the Part D Payment Modernization Model. CMS will host two sessions including the same content, which will take place on Thursday, January 31, 2019 at 1:00 p.m. EST, and on Wednesday, February 6, 2019 at 1:00 p.m. EST.

    If you previously registered for the Part D Payment Modernization Model webinar originally scheduled for Tuesday, January 29, 2019 please re-register for one of the new dates.

    During the webinar, CMS subject matter experts will provide information about The Part D Payment Modernization model, which tests the impact of modernized Part D program design and improved incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs. The model is open to eligible standalone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans that are approved to participate, is voluntary, and will last 5 years, beginning with the 2020 plan year.

    As part of the model, CMS will provide participants with additional programmatic tools, including Part D rewards and incentives programs, to increase engagement with enrollees, with the goal of promoting better enrollee understanding of: (1) their Part D benefit, including out-of-pocket and total drug costs; and (2) clinically equivalent therapeutic options.

    Register for the Thursday, January 31, 2019 webinar here.

    Register for the Wednesday, February 6, 2019 webinar here.

    Posted 1/29/2019

  • FDA Approves Ibrutinib Plus Obinutuzumab for CLL/SLL

    On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

    Read the Janssen press release here.

     Posted January 28, 2019

  • ACCC Joins in Letter to CMS Expressing Concerns with Proposed Part D & MA Rule

    The Association of Community Cancer Centers (ACCC) joined more than 30 stakeholder organizations in a January 25 letter to the Centers for Medicare & Medicaid Services (CMS) outlining concerns over the impact of the administration's proposed rule on Modernizing Part D and Medicare Advantage. The letter addresses the following issues addressed in the proposed rule:
    • Providing plan flexibility to manage protected classes
    • Application of step therapy for Part D drugs by Medicare Advantage plans
    • Explanation of benefits requirements
    • Changes to the definition of negotiated price
    • Pharmacy price concessions in negotiated price.
    Read the letter.

    Posted 1/25/19

  • Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma

    On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

    Read the Adaptive Biotechnologies press release here

    Posted 1/23/2019

  • FDA Approves Third Biosimilar to Trastuzumab

    On January 18, the FDA approved trastuzumab-dttb (Ontruzant, Samsung Bioepis), a biosimilar to trastuzumab (Herceptin), for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

    Read the OncLive news coverage here.

    Posted 1/18/19

  • CMMI to Test Part D Payment Model & Update to MA VBID Model

    On January 18, the Centers for Medicare & Medicaid Services (CMS) announced that its Center for Medicare and Medicaid Innovation (CMMI) will test a new model for Part D plans and an update to the Medicare Advantage Value-Based Insurance Design (VBID) model that the agency launched in 2017. 

    The Part D model, titled the Part D Payment Modernization model, is voluntary as is the MA VBID update model, meaning that certain Medicare Advantage and Part D plans can choose to participate, and patients can choose to enroll in participating plans. 

    The Part D Payment Modernization model will begin in January 2020. The model is intended to test the impact of a revised Part D program design and incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs.

    The voluntary, five-year Part D Modernization model will be open to eligible standalone Prescription Drug Plans (PDPs) and Medicare Advantage-Prescription Drug Plans (MA-PDs) that are approved to participate. 

    The CMS fact sheet on the Part D Modernization model states:
    "Through this model, CMS is testing the impact of a modernized Part D payment structure that increases and better aligns Part D plan sponsor liability with the costs paid for by CMS and Medicare beneficiaries. Ultimately, this model will allow CMS to address the high list price of drugs covered by Medicare Part D and evaluate the impact on cost and quality for Medicare beneficiaries."

    Read CMS fact sheet on Part D Modernization Model here.

    More information is available on the CMMI website here.

    The CMS press release is available here

    Posted 1/18/19